26 January 2010

Don't want to freak any one out.. but an informed consumer is a knowledgable consumer

Ok, we all have ports implanted under our skin.. when we go to get our fills the docs use something called a huber needle, They should be using a non-coring needle on us..  Anyway, the FDA just annouced a recall on some brands of huber needles I have bolded the brands below..  So the next time you go for a fill ask your doc or PA what kind of huber needle they are using and are they aware of the recall.. just passing some industry compliance info on..




NEWS RELEASE

For Immediate Release: Jan. 26, 2010
Media Inquiries: Peper Long, 301-796-4671, mailto:mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Announces Class I Recall of Certain Infusion Set Needles
Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions

The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.
Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate.

There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the following product codes or catalog numbers:

The full FDA Release is here..

FDA NEWS RELEASE ON RECALL

4 comments:

  1. Thanks Barbara. Good info.

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  2. Hey thanks for stopping by my blog and giving me the info on my severence. It never occurred to me but makes perfect sense. I appreciate that! Also thanks for the info in this post - great info. I look forward to reading up on your blog! thanks again!

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  3. Hey thanks for this info. To be informed is much better. :)

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